Abstract

This document defines the development and maintenance life cycle requirements for health software. The set of processer, activities and tasks described in this standard establishes a common framework for health software life cycle proceses.

Begin

2018-03-08

Planned document number

DIN EN 62304

Project number

02228170

Responsible national committee

DKE/UK 811.3 - Sicherheit von medizinisch genutzten Geräten/Systemen/Einrichtungen in der vernetzten Anwendung  

draft standard

Health software - Software life cycle processes (IEC 62A/1235/CDV:2018); German and English version prEN 62304:2018
2018-06
Order from DIN Media

previous edition(s)

Medical device software - Software life-cycle processes (IEC 62304:2006 + A1:2015); German version EN 62304:2006 + Cor.:2008 + A1:2015
2016-10

Order from DIN Media